Short Course Listings
Short Course

Course Information
Course Title: Modern HPLC and UHPLC for Practicing Scientists II
Categories: 1 - Life Sciences
2 - Liquid Chromatography
3 - Liquid Chromatography-Mass Spectrometry
4 - Pharmaceutical Sciences
5 - Quality/Regulatory/Compliance
6 - Teaching Analytical Chemistry
Instructor(s): Michael Dong Course Number: 13
Affiliation: MWD Consulting
Course Date: 03/05/2017 - Sunday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee: $70

Course Description
This advanced 1-day workshop will provide the analytical scientist with a clearer understanding and a solid working knowledge of the applications and practice of HPLC and UHPLC (ultra-high-pressure liquid chromatography). This is the second part of a two-course series. The first part, “Advanced HPLC/UHPLC 1”, is a course that focuses on the fundamentals (theory, column and instrument) of HPLC and UHPLC. The focus of the course is on pharmaceutical analysis of drug substances and drug products (small molecule drugs and recombinant biologics).

Target Audience
Analysts, scientists, researchers, and managers in pharmaceutical and biopharmaceutical companies who want to get an updated overview of fundamentals and best practice of modern HPLC/UHPLC in pharmaceutical analysis and other applications. A basic understanding of chemistry and HPLC with some hands-on experience is assumed

Course Outline
4. Pharmaceutical Analysis and other applications
A. An overview of pharmaceutical discovery and development processes, Intro, Glossary, high-throughput purification, preclinical research, chemistry, manufacturing and control (CMC), formulation, the role of the analytical chemist, techniques for physicochemical characterization, specification recommendations from IQ Consortium
B. An overview of analytical development and quality control in small molecule drugs development, potency assay, stability-indicating method, stability study, cleaning verification, a generic LC/UV/MS method for multiple active pharmaceutical ingredients (API), dissolution testing, chiral separations, certificates of analysis of drug substance and drug product
C. Analysis of recombinant biological products, overview of monoclonal antibodies (mAb), structure characteristics, bioprocessing, differences of small molecule drugs vs. mAb, specifications, case studies of QC of mAb using SEC, IEC, RPC, peptide mapping, and HIC, references
5. UHPLC 1: Concept and Benefits
A. Overview and perspectives, Glossary, the modern HPLC platform with higher performance, UHPLC concepts (the need for high pressure, void volume, peak volume, instrumental bandwidth), UV flow cell design, dwell volume
B. Benefits and case studies: very fast separations with good resolution, very high resolution analysis of complex samples, facilitating rapid method development, flexibility to increase resolution, a modernized generic method, the greener HPLC platform
6. UHPLC 2: Potential Issues, Practices, and implementation
A. Potential issues and how to mitigate (viscous heating, operating nuances, compatibility to existing methods, injection precision, detector sensitivity vs. mixing volumes)
B. Method translation (transfer) issues: method portability, method conversion (translation), What is method transfer, need for partial method validation, case studies
C. How to transition from HPLC to UHPLC, end-fittings, system performance tradeoffs, Myths in UHPLC, references

Course Instructor's Biography
Dr. Michael W. Dong is a principal consultant in MWD Consulting focusing on consulting and training services on HPLC/UHPLC, pharmaceutical analysis and drug quality. He was formerly Senior Scientist in Analytical Chemistry and Quality Control at Genentech, Research Director at Synomics Pharma, Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems / Perkin-Elmer. He holds a Ph.D. in Analytical Chemistry from the City University of New York, and a certificate in Biotechnology from U. C. Santa Cruz. He has 100+ publications including a bestselling book on chromatography (Modern HPLC for Practicing Scientists). He is an editorial advisory board member of LCGC magazine and American Pharmaceutical Review. Recommended textbook: M. W. Dong, Modern HPLC for Practicing Scientists, Wiley-Interscience, New Jersey, 2006 (ISBN-10: 047172789X).